PULmonary Stimulation for Asthma Relief

Part of paid clinical trials in Denver, Colorado.

Sponsor
Spiro Medical, Inc.
Study ID
NCT07709754
Status
Not Yet Recruiting

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Conditions

  • Moderate to Severe Asthma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulation — DEVICE
    Implantation of a Spinal Cord Stimulation system

Study Details

This study aims to assess the safety and efficacy of Pulmonary Neuromodulation in patients suffering from moderate to severe asthma

Key Dates

First listed
Jul 17, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Receives full Spinal Cord Stimulation implant on Day 0. Therapy is activated on Day 0. Safety and efficacy are assessed at 2 weeks, 1 month, 3 months, 4 months, 5 months and 6 months.
  • Sham Comparator: Delayed activation arm
    Receives full Spinal Cord Stimulation implant on Day 0. Therapy is activated on Day 90. Safety and efficacy are assessed at 2 weeks, 1 month, 3 months, 3.5 months, 4 months, 5 months and 6 months.

Primary Outcome Measure

ACT score [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206
Michael E Wechsler, MD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32611-

Find similar trials in Denver, CO

By research site
National Jewish Health· Denver, COUniversity of Florida· Gainesville, FL

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